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NCT ID: NCT00994292 Completed - Clinical trials for Acute Coronary Syndrome

Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes

RUBY-1
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.

NCT ID: NCT00993473 Completed - Clinical trials for Type 1 Diabetes Mellitus

6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

PRESCHOOL
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: - rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia - HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment - percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment - average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

NCT ID: NCT00993408 Completed - Clinical trials for Pulmonary Arterial Hypertension

Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)

Start date: April 30, 2008
Phase: Phase 2
Study type: Interventional

This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.

NCT ID: NCT00993382 Completed - Clinical trials for Ventricular Arrhythmia

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

ALPHEE
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The Primary Objective was to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary Objectives were: - To assess the tolerability and safety of the different dose regimens of celivarone in the selected population. - To document SSR149744 plasma levels during the study.

NCT ID: NCT00993226 Completed - Postoperative Pain Clinical Trials

An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

Start date: May 2009
Phase: Phase 2
Study type: Interventional

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.

NCT ID: NCT00992589 Completed - Clinical trials for Gastroesophageal Reflux

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

NCT ID: NCT00992394 Completed - Psoriasis Clinical Trials

Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept

ReSPONSE
Start date: January 2010
Phase: Phase 4
Study type: Interventional

This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment. The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

NCT ID: NCT00990626 Completed - Clinical trials for Schizophrenia Relapse Prevention

Seroquel XR in Schizophrenia Relapse Prevention

Start date: October 2009
Phase: N/A
Study type: Observational

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients

NCT ID: NCT00989131 Completed - Clinical trials for Fallopian Tube Cancer

Study of Paclitaxel in Patients With Ovarian Cancer

Start date: February 2009
Phase: Phase 3
Study type: Interventional

RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less. PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.

NCT ID: NCT00988208 Completed - Prostate Cancer Clinical Trials

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Mainsail
Start date: November 11, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.